At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Biomarker Data Collection (other), MK6240 (radiation)
- How long the study runs
- Study runs about 46 months (dates as stated)
- About the drug or intervention
- Biomarker Data Collection — other: During this study, a sample of your blood will be collected and you will have a PET scan taken of your brain. · MK6240 — radiation: Each participant will be assessed using either one of two radioactive tau PET tracers: Flortaucipir or MK6240.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is building a database to explore how digital tools and blood tests (biomarkers) relate to brain scans that show tau and amyloid proteins in older adults. It includes people aged 60 to 90 who are either cognitively normal, have mild cognitive impairment (MCI), or have mild-to-moderate Alzheimer's disease dementia. The sponsor is GAP Innovations, PBC.
Who can take part
- Aged 60 to 90 years
- Have a study partner who spends at least 8 hours a week with you and can describe your memory and daily abilities
- Give written consent (or a legally authorised representative consents for you)
- Willing to have a brain MRI (magnetic resonance imaging) scan within 90 days and amyloid and tau PET (positron emission tomography) scans within 120 days of consenting
- Willing to follow all study steps, including blood samples, genetic testing, and storing samples for future research
- Fluent in the language used for tests at the study site
- Willing to be contacted about other research trials after this study ends
- Mini-Mental State Exam (MMSE) score between 16 and 30 at screening
Who may not be able to
- Unable to have amyloid and tau PET scans (for example due to pregnancy, sensitivity to the substances used, poor vein access, or too much radiation exposure)
- Have had a negative amyloid PET scan in the past 6 months
- Any reason you cannot have a brain MRI scan
- Stroke or seizures within the past year
- Cancer within the past 5 years (except non-melanoma skin cancer or prostate cancer in situ)
- Alcohol or drug abuse or dependence within the past year
- Unstable psychiatric symptoms, such as uncontrolled depression, that could affect the study
- Have had a potential disease-modifying Alzheimer's treatment within the past 6 months
- HIV positive unless controlled by antiviral medicine
- Serious or unstable medical conditions that would stop you completing the study
- Untreated conditions such as vitamin B12 or folate deficiency or bladder infections that could affect memory
- Cognitive testing within 1 month before screening that could cause a practice effect
- Other neurological disorders affecting the brain (such as Parkinson's disease, other dementias, or repeated concussions) that may affect memory
- Geriatric Depression Scale (GDS) score of 8 or more at screening, if considered clinically significant depression
- Rey Auditory Verbal Learning Test (RAVLT) t-score of 1.2 standard deviations or more above the mean
- Weigh less than 110 pounds (about 50 kilograms)
- Direct employees of the study sites or the sponsor, or their family members
- Cannot complete memory tests due to eyesight or hearing problems
- For the RetiSpec retinal (eye) scan: allergy or reaction to Tropicamide 1% eye drops
What taking part involves
- • This is not a treatment trial — it collects information for a database
- • Blood tests, including genetic testing, with samples stored for future research
- • Brain MRI scan
- • Amyloid and tau PET brain scans
- • Memory and thinking tests
- • Optional sub-study: phone calls every 3 months, yearly clinic visits, and yearly amyloid and tau PET scans
Time commitment: Taking part involves screening visits, blood samples, memory tests, an MRI scan and PET scans within the first few months; a sub-study adds 3-monthly phone calls and annual clinic visits with yearly PET scans — total study duration: Not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 60 Years to 90 Years
- Who
- All
- Number of participants
- 1,200
- Started
- 2024-09-26
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for mild cognitive impairment
- • Clinical study - 1,200 participants
- • Bio-Hermes-002 is a 120-day cross-sectional study that will result in a blood, CSF, retinal, digital, MRI, and PET brain imaging biomarker database that can be used to determine the primary objective
Who can take part?
- • Ages 60 Years to 90 Years
- • Diagnosed with mild cognitive impairment
Where?
- • Motherwell - NeuroClin Glasgow
- • London - Re:Cognition Health
- • London - Dementia Research Centre, UCLH
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Bio-Hermes-002 is a 120-day cross-sectional study that will result in a blood, CSF, retinal, digital, MRI, and PET brain imaging biomarker database that can be used to determine the primary objective. Digital biomarkers and blood-based biomarkers will be tested to determine whether a meaningful relationship exists between biomarkers alone or in combination with tau or amyloid brain pathology identified through PET images.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 60 Years - 90 Years
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ a Mini-Mental State Exam (MMSE) score of 16 to 30 inclusive at screening
What the study is looking for
- ✓Pre-screening Inclusion Criteria
- ✓Participants must meet ALL of the following criteria to progress to Visit 1 (Screening):
- ✓Participant is between 60 to 90 years of age (inclusive) at the time of consent; and
- ✓Core Study Inclusion Criteria
- ✓Participants must be willing to undergo an MRI brain scan within 90 days and an amyloid and tau PET scan within 120...
Who cannot take part
- ✗Pre-screening Exclusion Criteria
- ✗Participants who meet ANY of the following criteria will not be eligible to progress to Visit 1 (Screening):
- ✗Participants who have reported or have a known negative amyloid PET scan in the past 6 months;
- ✗Participants with any known safety concern to brain MRI scan;
- ✗Participants with history of stroke or seizures within 1 year of the Pre-Screening Visit;
See the full criteria
Where Is This Study? (3 UK sites)
NeuroClin Glasgow
Motherwell ML1 4UF, United Kingdom
Re:Cognition Health
London W1G 8TA, United Kingdom
Dementia Research Centre, UCLH
London WC1N 3BG, United Kingdom
How to Get in Touch
Amanda Ng, MA
Sponsor contactCONTACT
